Valve apparatus, system and method

ABSTRACT

A cardiac valve with a first anchor frame and a cover on the first anchor frame for unidirectional flow of a liquid through the valve.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. application Ser. No.11/107,162 filed Apr. 15, 2005, the entire content of which isincorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates generally to apparatus, systems, andmethods for use in a lumen; and more particularly to a valve apparatus,systems, and methods for use in the vasculature system.

BACKGROUND OF THE INVENTION

Diseases of the heart valves are grouped according to which valve(s) areinvolved and the way blood flow is disrupted. The most common valveproblems occur in the mitral and aortic valves. Diseases of thetricuspid and pulmonary valves are fairly rare.

The aortic valve regulates the blood flow from the heart's leftventricle into the aorta. The aorta is the main vessel that suppliesoxygenated blood to the rest of the body. Diseases of the aorta can havea significant impact on an individual. Examples of such diseases includeaortic regurgitation and aortic stenosis.

Aortic regurgitation is also called aortic insufficiency or aorticincompetence. It is a condition in which blood flows backward from awidened or weakened aortic valve into the left ventricle of the heart.In its most serious form, aortic regurgitation is caused by an infectionthat leaves holes in the valve leaflets. Symptoms of aorticregurgitation may not appear for years. When symptoms do appear, it isbecause the left ventricle must work harder as compared to anuncompromised ventricle to make up for the backflow of blood. Theventricle eventually gets larger and fluid backs up.

Aortic stenosis is a narrowing or blockage of the aortic valve. Aorticstenosis occurs when the valve leaflets of the aorta become coated withdeposits. The deposits change the shape of the leaflets and reduce bloodflow through the valve. The left ventricle has to work harder ascompared to an uncompromised ventricle to make up for the reduced bloodflow. Over time, the extra work can weaken the heart muscle.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B illustrate an embodiment of a valve.

FIG. 2 illustrates an embodiment of a valve.

FIG. 3 illustrates an embodiment of a valve.

FIGS. 4A-4C illustrate an embodiment of a system that includes a valve.

FIGS. 5A-5C illustrate an embodiment of a system that includes a valve.

FIGS. 6A-6D illustrate an embodiment of a system that includes a valve.

DETAILED DESCRIPTION

Embodiments of the present invention are directed to an apparatus,system, and method for percutaneous cardiac valve replacement and/oraugmentation. For example, the apparatus can include a cardiac valvethat can be used to replace an incompetent valve (e.g., an aortic valve,a mitral valve, a tricuspid valve or a pulmonary valve) in a body lumen.Embodiments of the cardiac valve can include a first anchor frame andtwo or more leaflets that can be implanted through minimally-invasivetechniques into a body lumen, such as an artery or a vein. In oneexample, embodiments of the present invention may help to augment orreplace the function of a cardiac valve of individuals having heartvalve disease.

The Figures herein follow a numbering convention in which the firstdigit or digits correspond to the drawing Figure number and theremaining digits identify an element or component in the drawing.Similar elements or components between different Figures may beidentified by the use of similar digits. For example, 110 may referenceelement “10” in FIG. 1, and a similar element may be referenced as 210in FIG. 2. As will be appreciated, elements shown in the variousembodiments herein can be added, exchanged, and/or eliminated so as toprovide any number of additional embodiments of valve. In addition, aswill be appreciated the proportion and the relative scale of theelements provided in the figures are intended to illustrate theembodiments of the present invention, and should not be taken in alimiting sense.

Various embodiments of the invention are illustrated in the figures.Generally, the cardiac valve can be implanted within the fluidpassageway of a body lumen, such as for replacement or augmentation of acardiac valve structure within the body lumen (e.g., an aortic valve atthe aortic root), to regulate the flow of a bodily fluid through thebody lumen in a single direction. The embodiments of the cardiac valveof the present invention attempt to maximize the effective area of theopening through the cardiac valve. In addition to maximizing theeffective area of the opening, the valve leaflets used with the cardiacvalve are believed to provide an improvement in the hemodynamicsperformance of the cardiac valve. For example, it is believed that theembodiments of the present invention help to increase the area of theoutflow through the valve, and thus provide for a lower pressuregradient across the valve. As such, embodiments of the present inventionare believed to provide not only a large effective flow area relativethe total area covered by the valve, but also improved hemodynamicperformance of the cardiac valve.

FIGS. 1A and 1B illustrate one embodiment of a cardiac valve 100. FIGS.1A and 1B provide a perspective illustration of valve 100 in an openconfiguration (FIG. 1A) and a closed configuration (FIG. 1B). Cardiacvalve 100 includes a first anchor frame 102, two or more leaflets 104,and two or more anchor members 106. The first anchor frame 102 includesa surface 108 defining an opening 110 through the first anchor frame102. The leaflets 104 are coupled to the first anchor frame 102, as willbe discussed herein, where the leaflets 104 can repeatedly move betweenan open state (FIG. 1A) and a closed state (FIG. 1B) for unidirectionalflow of a liquid through the opening 110 of the cardiac valve 100.

As illustrated, the anchor members 106 extend vertically over thesurface 108 defining the opening 110 through the first anchor frame 102when the cardiac valve 100 is in its fully deployed configuration. Forexample, in one embodiment the anchoring members 106 extend parallelwith a common axis 112 that is perpendicular to a common plane 114extending through the first anchor frame 102. In an additionalembodiment, the anchoring members 106 can extend at an acute angle 116relative the common plane 114 extending through the first anchor frame102.

The first anchor frame 102 can, in addition, have a variety of flexibleconfigurations and be formed from a variety of materials. For example,the first anchor frame 102 can have an overall ring like configurationtaken along the common plane 114, where the ring is radiallycompressible due the zigzag and/or serpentine configuration of the frame102. As will be appreciated, the ring like configuration can include,but is not limited to, circular, elliptical, and variations on thoseshapes that may be useful in allowing the shape of the first anchorframe 102 to more closely conform to the physiological shape (e.g., thefibrous ring surrounding the orifice of the cardiac valve that is beingaugmented or replaced) and/or environment into which the cardiac valve100 is being implanted. In addition, as will be appreciated the flexibleconfiguration is not limited to the zigzag and/or serpentineconfiguration, but is only used as one illustration of such a flexibleconfiguration. As such, the present invention should not be limited tothe illustration of the first anchor frame 102. In addition, the firstanchor frame 102 need not necessarily have a planar configuration, butcan also include non-planar configurations as necessary to best conformto the native physiological shape and/or environment into which thecardiac valve 100 is being implanted.

The first anchor frame 102 can also be configured to display a minimalsurface area relative the surface area common plane 114. In oneembodiment, this minimal surface area can be tailored to match to thesurface area of the fibrous ring surrounding the orifice of the cardiacvalve that is being augmented or replaced with the cardiac valve 100. Inthis way, the amount of surface area for the opening 110 of the cardiacvalve 100 can more closely match the surface area of the opening for thenative cardiac valve that is being replaced or augmented. In otherwords, the first anchor frame 102 can have a predetermined circumferencethat allows for sufficient contact with the fibrous ring surrounding theorifice of the cardiac valve while maximizing the surface area of theopening of the cardiac valve 100.

In one embodiment, the first anchor frame 102 can be formed of one ormore frame members 117. The frame members 117 can also have dimensionsthat assist in providing the first anchor frame 102 with the minimalsurface area relative the surface area common plane 114. The exactdimensions for the frame members 117 will depend upon theircross-sectional shape and also their configuration. In one embodiment,the surface area of the opening 110 can be from 3.0 cm² to 4.0 cm². Aswill be appreciated, the exact surface area of the opening 110 will bedetermined based on the specific patient.

In addition, the cardiac valve 100 can have a diameter from 15 mm to 36mm, which exact size will be dependent upon the size and type of valvebeing replaced. The frame members 117 can have a diameter from 0.07 mmto 0.51 mm depending on the valve support material and the targetanatomy. The valve 100 can also include a height from 1 cm to 6 cmdepending on the valve being replaced and patient size.

The frame members 117 can have one or more of a variety ofcross-sectional shapes and dimensions. For example, the frame members117 can have a tubular and/or a solid cross-sectional configuration. Inaddition, the frame members 117 can have cross-sectional shapes thatinclude, but are not limited to, circular, elliptical or oval, I-shaped,T-shaped, triangular, rectangular, and/or polygonal (i.e., multi-sidedshapes). The members can also have a single cross-sectional shape (e.g.,all members of frame 102 can have a circular cross-sectional shape). Inan additional embodiment, the members of the first anchor frame 102 caninclude two or more cross-sectional shapes. In addition, the type ofdelivery technique that will be used with the cardiac valve 100, asdiscussed herein, can also have an influence on the shape andconfiguration of the first anchor frame 102 used with the cardiac valve100.

The frame members 117 of the first anchor frame 102 can be formed from awide variety of materials. Generally, the first anchor frame 102 has aunitary structure that can have a configuration that allows the frame102 to be radially expandable through the use of a balloon catheter, aswill be discussed herein. In an alternative embodiment, the first anchorframe 102 can also be self-expanding. Examples of self-expanding framesinclude those formed from temperature-sensitive memory alloy whichchanges shape at a designated temperature or temperature range.Alternatively, the self-expanding frames can include those having aspring-bias.

The first anchor frame 102 can be formed from any number of materials.For example, the first anchor frame 102 can be formed from abiocompatible metal, metal alloy, polymeric material, or combinationthereof. As discussed herein, the first anchor frame 102 can beself-expanding or balloon expandable. In addition, the first anchorframe can be configured so as to have the ability to move radiallybetween the collapsed state and the expanded state. To accomplish this,the material used to form the first anchor frame should exhibit a lowelastic modulus and a high yield stress for large elastic strains thatcan recover from elastic deformations. Examples of suitable materialsinclude, but are not limited to, medical grade stainless steel (e.g.,316L), titanium, tantalum, platinum alloys, niobium alloys, cobaltalloys, alginate, or combinations thereof. Additional anchor frameembodiments may be formed from a shape-memory material, such as shapememory plastics, polymers, and thermoplastic materials which are inertin the body. Shaped memory alloys having superelastic propertiesgenerally made from ratios of nickel and titanium, commonly known asNitinol, are also possible materials. Other materials are also possible.

The frame members 117 of the first anchor frame 102 can also be shaped,joined and/or formed in a variety of ways. For example, a singlecontiguous member can be bent around a tubular mandrel to form the firstanchor frame 102. The free ends of the single contiguous member can thenbe welded, fused, crimped, or otherwise joined together to form thefirst anchor frame 102. Alternatively, the first anchor frame 102 can bederived (e.g., laser cut, water cut) from a single tubular segment. Thefirst anchor frame 102 can be annealed to relieve internal stress andsubsequently polished by methods as is typically known for the materialwhich forms the first anchor frame 102.

In addition, the anchor members 106 can also be joined and/or formedfrom the frame members 117 of the first anchor frame 102. For example,anchor members 106 can be separately formed from and then attached tothe first anchor frame 102. The anchor members 106 can be welded, fused,crimped, or otherwise joined to the first anchor frame 102 as describedherein. In an additional embodiment, the anchor members 106 can beformed from at least a portion of the frame members 117. For example,segments of the frame members 117 could be cut and then bent so as toform the anchor members 106 extending vertically over the surface 108defining the opening 110 through the first anchor frame 102, asdiscussed herein.

As illustrated in FIGS. 1A and 1B, the anchor members 106 can eachinclude a first end 118 and a second end 120. The first and second ends118 and 120 each have a size and configuration that are adapted to bothpenetrate tissue (e.g., the fibrous tissue that surrounds cardiacvalves) and to anchor the cardiac valve 100 to the tissue.

A variety of structures and configurations of the anchor members 106 areavailable for anchoring the cardiac valve 100 to the tissue. Forexample, one or both of the first end 118 and the second end 120 caninclude a barb for penetrating and anchoring the cardiac valve 100 tothe tissue. In an additional embodiment, the anchor members 106 can havematerial characteristics that allow the cardiac valve 100 to be securedto the cardiac tissue. For example, the anchor members 106 can beconstructed and shaped in such a way that the first and second ends 118and 120 of the anchor members 106 have a driving force to move from afirst predetermined shape to a second predetermined shape to anchor thecardiac valve 100 to tissues. In one embodiment, this movement can be onaccount of the first and second ends 118 and 120 of the anchor members106 being restrained or held in the first predetermined position undertension. When no longer restrained, the first and second ends 118 and120 of the anchor members 106 move back towards the second predeterminedposition. An embodiment of the second predetermined position isillustrated in FIGS. 1A and 1B. In one embodiment, the first and secondends 118 and 120 are held in tension due to the presence of a deploymentmember that can be removed from between the first and second ends 118and 120, as will be discussed more fully herein.

The anchor members 106 can also have a variety of shapes that allow forthe first and second ends 118 and 120 to be held under tension, as willbe discussed more fully herein. For example, the anchor members 106 canbe held under tension so as to have an overall U-shaped configuration,an overall square configuration (e.g., an un-bend staple configuration),and/or V-shaped configuration. After removing the restraint, one or bothof the first and second ends 118 and 120 moves relative to each other toanchor the cardiac valve 100 to the cardiac tissue. For example, one orboth of the first and second ends 118 and 120 can move towards eachother thereby trapping and/or compressing tissue in their travel path.Alternatively, the first and second ends 118 and 120 can move so as topierce through a portion of the cardiac tissue so as to embed barbs onthe first and second ends 118 and 120 more fully into the cardiactissue. In an additional example, the first and second ends 118 and 120can move to provide a hooked end portion (i.e., a J-shaped end) of theanchor member 106. Other shapes and configurations are also possible.

The anchor members 106 can be formed from a wide variety of materials,such as those described herein for the first anchor frame 102 (e.g.,stainless steel, nitinol). In addition, the anchor members 106 heldunder tension extend over the surface 108 of the first anchor frame 102,as discussed herein, by a predetermined distance. In one embodiment, thepredetermined distance is sufficient to allow the first and second ends118 and 120 of the anchor members 106 to engage the cardiac tissue(e.g., the fibrous ring surrounding the cardiac valve) sufficiently wellso that when the deployment member, discussed herein, is removed themotion of the first and second ends 118 and 120 draws the anchor members106 further into the cardiac tissue. As such, the length of the anchormembers 106 used for the cardiac valve 100 will be dependent upon theimplant location of the valve 100.

While the anchor members 106 are shown positioned completely around thefirst anchor frame 102, other placement configurations for the anchormembers 106 are possible. For example, the anchor members 106 may beequally spaced around the first anchor frame 102. Alternatively, theanchor members 106 may be unequally spaced around the first anchor frame102, where portions of the first anchor frame 102 may have relativelyfew or no anchor members 106 as compared to similar sized areas on thefirst anchor frame 102. In other words, there may be regions of thefirst anchor frame 102 where there are gaps in the placement of theanchor members 106. In one embodiment, this can be done to accommodatethe physiological environment into which the cardiac valve 100 is to beimplanted. For example, the region of the cardiac valve may not presentenough fibrous tissue, or it may be too small of an area, to effectivelyimplant the anchor members 106.

The cardiac valve 100 can further include one or more radiopaque markers(e.g., tabs, sleeves, welds). For example, one or more portions of thefirst anchor frame 102 can be formed from a radiopaque material.Radiopaque markers can be attached to and/or coated onto one or morelocations along the first anchor frame 102. Examples of radiopaquematerial include, but are not limited to, gold, tantalum, and platinum.The position of the one or more radiopaque markers can be selected so asto provide information on the position, location and orientation of thevalve 100 during its implantation.

The cardiac valve 100 further includes leaflets 104 having surfacesdefining a reversibly sealable opening 122 for unidirectional flow of aliquid through the valve 100. For example, the leaflets 104 can becoupled to the first anchor member 102 so as to span and control fluidflow through the opening 110 of the cardiac valve 100. In oneembodiment, the leaflets 104 can be derived from a xenograft cardiacvalve. As will be appreciated, sources for xenograft cardiac valvesinclude, but are not limited to, mammalian sources such as porcine,equine, and sheep.

In one embodiment, the leaflets 104 are provided by a valve root 124derived from the xenographic donor. The valve root 124 includes theleaflets 104 of the valve along with a segment of the native valve withwhich to couple to the first anchor frame 102. For example, the valveroot 124 can include an aortic root that includes both the leaflets andthe segment of the aortic root sufficiently large enough to allow theaortic root to be coupled to the first anchor frame 102. Other valveroots besides the aortic root can be used with the embodiments of thepresent invention (e.g., a mitral valve root having two leaflets).

The valve root 124 can be mounted to the first anchor frame 102 in avariety of ways. For example, the first anchor frame 102 can include asewing cushion 126 to which the valve root 124 can be attached. In oneembodiment, the sewing cushion 126 can be coupled to the surface 108 ofthe first anchor frame 102 adjacent the anchor members 106. In analternative embodiment, the sewing cushion 126 can be coupled to thesurface 108 of the first anchor frame 102 where the sewing cushion 126extends around the anchor members 106 so as not to interfere with theirfunction. In an additional embodiment, the sewing cushion 126 can have aporous structure to allow for the in growth of tissue into the fabric.

The valve root 124 can then be coupled to the first anchor frame 102 ina number of ways that allow the leaflets 104 to be functionallypositioned within the opening 110 of the cardiac valve 100. In oneembodiment, the valve root 124 can be stitched to the sewing cushion 126so that the valve root 124 is positioned completely within a perimeterdefined by the anchoring members 106. Alternatively, the valve root 124could be modified so as to be positioned at least partially on thesewing cushion while also being at least partially positioned around theanchoring members 106.

In addition to stitching, there are other techniques may be employed tosecure the leaflets 104/valve root 124 to the first anchor frame 102including the sewing cushion 126. These techniques can include, but arenot limited to, the use of fasteners (such as biocompatible staples,glues), heat setting, adhesive welding, interlocking, application ofuniform force and other bonding techniques, including methods describedin U.S. Patent Application Publication US 2002/0178570 to Sogard et al.or combinations thereof. In an additional embodiment, the valve root 124can be coupled to the first anchor frame 102 through the use of heatsealing, solvent bonding, adhesive bonding, or welding the valve root124 to either a portion of the valve root 124 (i.e., itself) and/or thefirst anchor frame 102.

In an additional embodiment, the valve root 124 discussed herein couldalso be completely or partially constructed of natural or syntheticmaterials. Natural materials include, without limitation, standardporcine heart valves, equine heart valves, sheep heart valves, modifiednatural heart valves include those having a leaflet with a septal shelfreplaced with a leaflet from another valve, and natural tissue valveswherein the cusps of the valve are formed from separate pieces ofpericardial or fascia lata tissue.

Synthetic materials include, without limitation, those materialssufficiently thin and pliable so as to permit radially-collapsing of thevalve leaflets for delivery by catheter to a location within a bodylumen. For example, the leaflets 104 can be constructed of abiocompatible material that can be either synthetic or biologic or acombination of synthetic and biologic biocompatible material. Possiblesynthetic materials include, but are not limited to, expandedpolytetrafluoroethylene (ePTFE), polytetrafluoroethylene (PTFE),polystyrene-polyisobutylene-polystyrene (SIBS), polyurethane, segmentedpoly(carbonate-urethane), polyester, polyethlylene (PE), polyethyleneterephthalate (PET), silk, urethane, Rayon, Silicone, or the like. In anadditional embodiment, the synthetic material can also include metals,such as stainless steel (e.g., 316L) and nitinol. These syntheticmaterials can be in a woven, a knit, a cast or other known physicalfluid-impermeable or permeable configurations.

Additional biologic materials include, but are not limited to,autologous, allogeneic or xenograft material. These include explantedveins, pericardium, facia lata, harvested cardiac valves, bladder, veinwall, various collagen types, elastin, intestinal submucosa, anddecellularized basement membrane materials, such as small intestinesubmucosa (SIS), amniotic tissue, or umbilical vein.

The first anchor frame 102, the sewing cushion 126, the leaflets 104and/or the valve root 124 may also be treated and/or coated with anynumber of surface or material treatments. For example, suitablebioactive agents which may be incorporated with or utilized togetherwith the present invention may be selected from silver antimicrobialagents, metallic antimicrobial materials, growth factors, cellularmigration agents, cellular proliferation agents, anti-coagulantsubstances, stenosis inhibitors, thrombo-resistant agents, antibioticagents, anti-tumor agents, anti-proliferative agents, growth hormones,antiviral agents, anti-angiogenic agents, angiogenic agents,cholesterol-lowering agents, vasodilating agents, agents that interferewith endogenous vasoactive mechanisms, hormones, their homologs,derivatives, fragments, pharmaceutical salts and combinations thereof.

In the various embodiments of the present invention, the most usefulbioactive agents can include those that modulate thrombosis, those thatencourage cellular ingrowth, throughgrowth, and endothelialization,those that resist infection, and those that reduce calcification. Forexample, coating treatments can include one or more biologically activecompounds and/or materials that may promote and/or inhibit endothelial,smooth muscle, fibroblast, and/or other cellular growth onto or into theframe 102 and/or the valve root 124, including the leaflets 104.Examples of such coatings include, but are not limited to, polyglacticacid, poly-L-lactic acid, glycol-compounds, and lipid compounds.Additionally, coatings can include medications, genetic agents, chemicalagents, and/or other materials and additives. In addition, agents thatlimit or decrease cellular proliferation can be useful. Similarly, theframe 102 and/or the valve root 124, including the leaflets 104, may beseeded and covered with cultured tissue cells (e.g., endothelial cells)derived from a either a donor or the host patient which are attached tothe valve leaflets 104. The cultured tissue cells may be initiallypositioned to extend either partially or fully over the valve leaflets104.

Cells can be associated with the present invention. For example, cellsthat have been genetically engineered to deliver bioactive proteins,such as the growth factors or antibodies mentioned herein, to theimplant site can be associated with the present invention. Cells can beof human origin (autologous or allogenic) or from an animal source(xenogenic). Cells can be pre-treated with medication or pre-processedsuch as by sorting or encapsulation. The delivery media can beformulated as needed to maintain cell function and viability.

Thrombo-resistant agents associated with the valve may be selected from,but not limited to, heparin, heparin sulfate, hirudin, hyaluronic acid,chondroitin sulfate, dermatan sulfate, keratin sulfate, PPack(detropyenylalanine praline arginine chloromethylketone), lytic agents,including urokinase and streptokinase, their homologs, analogs,fragments, derivatives and pharmaceutical salts thereof.

Anti-coagulants can include, but are not limited to, D-Phe-Pro-Argchloromethyl ketone, an RGD peptide-containing compound, heparain,antithrombin compounds, platelet receptor antagonists, anti-thrombinantibodies, anti-platelet receptor antibodies, aspirin, prostaglandininhibitors, platelet inhibitors, tick antiplatelet peptides andcombinations thereof.

Antibiotic agents can include, but are not limited to, penicillins,cephalosportins, vancomycins, aminoglycosides, quinolonges, polymyxins,erythromycins, tetracyclines, chloraphenicols, clindamycins,lincomycins, sulfonamides, their homologs, analogs, derivatives,pharmaceutical salts and combinations thereof.

Anti-proliferative agents for use in the present invention can include,but are not limited to, the following: paclitaxel, sirolimus,everolimus, or monoclonal antibodies capable of blocking smooth musclecell proliferation, related compounds, derivatives, and combinationsthereof.

Vascular cell growth inhibitors can include, but are not limited to,growth factor inhibitors, growth factor receptor antagonists,transcriptional repressors, translational repressors, replicationinhibitors, inhibitory antibodies, antibodies directed against growthfactors, bifunctional molecules consisting of a growth factor and acytotoxin, bifunctional molecules consisting of a an antibody and acytotoxin.

Vascular cell growth promoters include, but are not limited to,transcriptional activators and transcriptional promoters.Anti-inflammatory agents can include, but are not limited to,dexametbasone, prednisolone, corticosterone, budesonide, estrogen,sulfasalazinemesalamne, and combinations thereof.

Although the embodiments in FIGS. 1A and 1B illustrate and describe atri-leaflet configuration for the valve 100 of the present invention,designs employing a different number of valve leaflets are possible. Forexample, bi-leaflet configurations (e.g., mitral valve) are alsopossible.

FIG. 2 illustrates an embodiment of the valve 200 where the anchormembers 206 extend from the first anchor frame 202 has just the firstend 218. In other words, the anchor members 206 have a single shaftextending from the first anchor frame 202 that ends with the first end218. As discussed herein, the anchor members 206 extend vertically overthe surface 208 defining the opening 210 through the first anchor frame202 when the cardiac valve 200 is in its fully deployed configuration.For example, in one embodiment the anchoring members 206 extend parallelwith a common axis 212 that is perpendicular to a common plane 214extending through the first anchor frame 202. In an additionalembodiment, the anchoring members 206 can extend at an acute angle 216to the common axis 212 that is perpendicular to the common plane 214extending through the first anchor frame 202.

As discussed herein, the first end 218 of the anchor members 206 eachhave a size and configuration that are adapted to both penetrate tissue(e.g., the fibrous tissue that surrounds cardiac valves) and to anchorthe cardiac valve 200 to the tissue. In addition, a variety ofstructures and configurations of the anchor members 206 are availablefor anchoring the cardiac valve 200 to the tissue. For example, thefirst end 218 can include a barb for penetrating and anchoring thecardiac valve 200 to the tissue.

In an additional embodiment, the anchor members 206 can have materialcharacteristics that allow the cardiac valve 200 to be secured to thecardiac tissue, as discussed herein. For example, the anchor members 206can be imparted with a driving force to move from a first predeterminedshape to a second predetermined shape to anchor the cardiac valve 200 totissues. In one embodiment, this movement can be on account of the firstend 218 of the anchor members 106 being restrained or held in the firstpredetermined position under tension. When no longer restrained, thefirst end 218 of the anchor members 206 move back towards the secondpredetermined position. In the present example, the first end 218 of theanchor members 206 move in a radial direction toward the perimeter ofthe first anchor frame 202. In one embodiment, the first end 218 areheld in tension due to the presence of a deployment member that can beradially compressing the first end 218 of the anchor members 206, aswill be discussed more fully herein.

The anchor members 206 can also have a variety of shapes that allow forthe first end 218 to be held under tension. For example, the anchormembers 206 can be held under tension so as to have an overalllinear-shaped configuration. After removing the restraint, the first end218 moves radially to anchor the cardiac valve 200 to the cardiactissue. For example, the first end 218 of the anchor members 206 canmove radially from the opening 210 to take on a J-shaped configuration,thereby drawing and securing the valve 200 into the cardiac tissuesurrounding native cardiac valve. Other shapes and configurations arealso possible. The first end 218 of the anchor member 206 can alsoinclude a barb, as discussed herein.

The anchor members 206 can be formed from a wide variety of materialsand can display the same dimensions relative the first anchor frame 202(e.g., extending of the surface 208 of the first anchor frame 202 by thepredetermined distance), as discussed herein. In addition, while theanchor members 206 are shown positioned completely around the firstanchor frame 202, other placement configurations for the anchor members206 are possible, as discussed herein.

FIG. 3 illustrates an additional embodiment of the cardiac valve 300.The cardiac valve 300 includes the first anchor frame 302, two or moreleaflets 304, and two or more anchor members 306, as discussed herein.In addition, the cardiac valve 300 further includes a second anchorframe 328 connected to the first anchor frame 302 through struts 329extending between the first anchor frame 302 and the second anchor frame328. In one embodiment, the leaflets 304 can be coupled to the struts329 and the first anchor frame 302. In addition, the struts 329 canallow for tension to be developed between the first and second anchorframes 302 and 328 when the cardiac valve 300 is implanted, as will bemore fully discussed herein.

The second anchor frame 328 includes a surface 330 defining an opening332 through the second anchor frame 328. The second anchor frame 328 canoptionally include leaflets, as discussed herein, for unidirectionalflow of the liquid through the opening 332.

The second anchor frame 328 further includes two or more anchor members334 extending from the surface 330 of the second anchor frame 328. Asillustrated, the anchor members 334 extend at an acute angle 316 to thecommon plane 336 extending through the second anchor frame 328 when thecardiac valve 300 is in its fully deployed configuration. In anadditional embodiment, the anchoring members 334 can extendperpendicular to the common axis 312 that is parallel to the commonplane 336 extending through the second anchor frame 328 (i.e., theanchoring members 334 can be parallel with the common plane 336).

The second anchor frame 328 can have a variety of configurations and canbe formed from a variety of materials, as were discussed herein for thefirst anchor frame 302. In addition, the second anchor frame 328 can beconfigured to be implanted in an artery or vein, while the first anchorframe 302 resides in the fibrous ring surrounding the orifice of thecardiac valve that is being augmented or replaced with the cardiac valve300. For example, the second anchor frame 328 can be configured to beimplanted in the aorta, while the first anchor frame 302 resides in thefibrous ring surrounding the orifice of the aortic valve. Otherlocations are possible.

In addition, the anchor members 334 can also be joined and/or formedfrom the same materials and/or the frame members of the second anchorframe 328, as discussed herein for the first anchor frame 302. Asillustrated in FIG. 3, the anchor members 334 can each include at leasta first end 338, where the anchor members 334 have a size andconfiguration that are adapted to both embed into the tissue (e.g., theartery or vein) and to help anchor the cardiac valve 300.

A variety of structures and configurations of the anchor members 334 areavailable for anchoring the cardiac valve 300 to the tissue. Forexample, the first end 338 can include a barb for penetrating andanchoring the cardiac valve 300. In addition, while the anchor members334 are shown positioned completely around the second anchor frame 328,other placement configurations for the anchor members 334 are possiblesuch as those discussed herein for the anchor members 306.

In an additional embodiment, the anchor members 334 can have dimensionaland material characteristics that allow the cardiac valve 300 to besecured to the cardiac tissue, as discussed herein for anchor members306. For example, the anchor members 334 can be constructed and shapedin such a way that the first ends 338 of the anchor members 334 have adriving force to move from a first predetermined shape to a secondpredetermined shape to anchor the cardiac valve 300, as discussed hereinfor anchor members 306. In one embodiment, this movement can be onaccount of the first ends 338 of the anchor members 334 being restrainedor held in the first predetermined position under tension. When nolonger restrained, the first ends 338 of the anchor members 334 moveback towards the second predetermined position. An embodiment of thesecond predetermined position is illustrated in FIG. 3. In oneembodiment, the first second ends 338 are held in tension due to thepresence of a deployment member that can be removed from the first ends338 and 120, as will be discussed more fully herein.

The anchor members 334 can also have a variety of shapes that allow forthe first ends 338 to be held under tension, as will be discussed morefully herein. For example, the anchor members 334 can be held undertension so as to have an overall linear configuration that changes tohave a hooked end portion (i.e., a J-shaped end) after removing therestraint. Other shapes and configurations are also possible.

As illustrated, the cardiac valve 300 includes struts 329 that connectthe second anchor frame 328 to the first anchor frame 302. In oneembodiment, the struts 329 can generally have a circular cross sectionand be of substantially uniform diameter throughout their entire extent.Alternatively, the struts 329 can have a rectangular profile. As will beappreciated, other cross-sectional shapes are also possible (e.g.,square, triangular, oval, etc.). In one embodiment, the cross-sectionalshape of the struts 329 is the same as the cross-sectional shape of theframe members of the first and second anchor frames 302 and 328.

FIG. 3 provides an illustration in which the struts 329 extend linearlybetween the valve 300 and the second anchor frame 328. As will beappreciated, the struts 329 can have a number of differentcross-sectional and elongate configurations. For example, the struts 329may have a rectangular profile and extend between the valve 300 and thesecond anchor frame 328 in a serpentine shape. In one embodiment, thecross-sectional shape and elongate configurations of the struts 329 canallow for additional contact area to be provided between the struts 329and the tissue of the implant site. For example, the rectangularcross-sectional shape and the serpentine elongate configuration canallow for aligning and confining the patients existing cardiac valveleaflets in an open position during and after the implantation of thecardiac valve 300.

As illustrated in FIG. 3, the struts 329 can be integral to the firstand second anchor frames 302 and 328. Alternatively, the struts 329 canbe separately coupled to the first and second anchor frames 302 and 328through the coupling processes described herein or that are known. Inaddition, the struts 329 can allow for tension to be developed betweenthe first and second anchor frames 302 and 328 when the cardiac valve300 is implanted, as will be more fully discussed herein.

In an additional embodiment, the struts 329 can be configured to extendinto the opening 310 of the first anchor frame 302. This allows, besidesother things, for the struts 329 to be clear of the vertically orientedanchoring members 306. The struts 329 can then arch back radially tocouple to the second anchor frame 328.

The struts 329 may be formed of, for example, any material which isnon-corrosive, fatigue resistant, and biocompatible. Examples of suchmaterials have been provided herein in connection with the first andsecond anchor frames 302 and 328. As will be appreciated, the first andsecond anchor frames 302 and 328 and the struts 329 can be formed fromin a single piece (e.g., through a laser or water cutting process) oftubular material. Alternatively, each of the first and second anchorframes 302 and 328 and the struts 329 could be formed separately andthen coupled as described herein. The edges of the resulting structurecan then be polished and contoured.

In addition to joining the first and second anchor frames 302 and 328,the configuration of the struts 329 also allow for additional options incoupling the leaflets 304 to the valve 300. For example, at least partof the leaflets 304, as discussed herein, can be coupled to the struts329 and the first anchor frame 302 to provide the reversibly sealableopening 322 for unidirectional flow of a liquid through the valve 300.As will be appreciated, the valve root 324 derived from the xenographicdonor can also be coupled to at least part of both the struts 329 andthe first anchor frame 302.

The valve root 324 can be mounted to the first anchor frame 302 and thestruts 329 in a variety of ways. For example, the first anchor frame 302and the struts 329 can both include a least a portion of the sewingcushion 326 to which the valve root 324 can be attached. The valve root324 can then be stitched to the sewing cushion 326, as discussed herein.Other coupling techniques, as discussed herein, could also be used. Inan additional embodiment, the valve root 324 can be coupled to the firstanchor frame 302 and/or the struts 329 through the use of heat sealing,solvent bonding, adhesive bonding, or welding the valve root 324 toeither a portion of the valve root 324 (i.e., itself) and/or the firstanchor frame 302 and the struts 329.

FIGS. 4A-4C illustrate one embodiment of a system 440. System 440includes valve 400, as described herein, releasably joined to a deliverycatheter 442. FIG. 4A illustrates an embodiment in which the valve 400in an undeployed configuration is releasably joined to a deliverycatheter 442. FIG. 4B illustrates an embodiment in which the valve 400is in its fully deployed configuration while being releasably joined toa delivery catheter 442. Finally, FIG. 4C illustrates an embodiment inwhich the valve 400 in its fully deployed configuration has beenreleased from the delivery catheter 442. In one embodiment, the valve400 can be reversibly joined to the delivery catheter 442 through theuse of one or more deployment members 444, as will be discussed below.

In the example illustrated in FIGS. 4A-4C, the delivery catheter 442includes an elongate body 446 having a proximal end 448 and a distal end450, where valve 400 can be located between the proximal end 448 anddistal end 450. The delivery catheter 442 further includes a firstdelivery lumen 452, a second delivery lumen 454, and a third deliverylumen 456 extending from the proximal end 448 towards the distal end 450of the delivery catheter 442.

The delivery catheter 442 also includes a first placement guide 458, asecond placement guide 460, and a third placement guide 462. Each of thefirst, second, and third placement guides 458, 460, and 462 has anelongate body 464 with a lumen 466 extending there through. Asillustrated in FIGS. 4A-4C, each of the first, second, and thirdplacement guides 458, 460, and 462 are positioned and can travellongitudinally within their respective delivery lumens 452, 454, and456. In one embodiment, this allows at least a portion of the first,second, and third placement guides 458, 460, and 462 to extend beyondthe distal end 450 of the delivery catheter 442.

The delivery catheter 442 also has deployment members 444 that extendthrough the lumens of the first, second, and third placement guides 458,460, and 462. In one embodiment, the deployment members 444 extendbeyond the first, second, and third placement guides 458, 460, and 462and are releaseably positioned adjacent the anchoring members 406. Forexample, the deployment members 444 can be releaseably positioned so asto constrain the first end 418 and the second end 420 of the anchormembers 406 in the first predetermined relationship. The deploymentmembers 444 can then be retracted from their positions relative theanchoring members 406, whereupon the first end 418 and the second end420 of the anchor members 406 to move to the second predeterminedrelationship.

Referring now to FIG. 4A, there is illustrated the system 440 with thevalve 400 in an undeployed configuration releasably coupled to thedelivery catheter 442. In one embodiment, the valve 400 can bereleasably coupled to the delivery catheter 442 through the deploymentmembers 444. For example, the deployment members 444 can extend from oneor more of the first, second, and third placement guides 458, 460, and462 to contact the anchor members 406. As discussed above, the anchormembers 406 are constructed and shaped in such a way that the first andsecond ends 418 and 420 of the anchor members 106 have a driving forceto move from a first predetermined shape to a second predetermined shapeto anchor the cardiac valve 400 to tissues. In one embodiment, thismovement can be on account of the first and second ends 418 and 420 ofthe anchor members 406 being restrained or held in the firstpredetermined position under tension by the presence of the deploymentmembers 444.

In addition to holding the first and second ends 418 and 420 of theanchor members 406 in the first predetermined position under tension,the deployment members 444 also releasably couples the valve 400 to thedelivery catheter 442. In the embodiment illustrated in FIG. 4A thevalve 400 has been coupled to the delivery catheter 442 in itsundeployed configuration. In one embodiment, in its undeployedconfiguration the valve 400 has been radially compressed (e.g., thefirst anchor frame 402 has been radially compressed) to reduce the sizeof the valve 400. As illustrated in FIG. 4A, the valve 400 in itsundeployed configuration can further be held in place (e.g.,constrained) by the presence of a retractable sheath 466 positionedadjacent the distal end 450 of the delivery catheter 442.

In one embodiment, the retractable sheath 466 can be positioned over atleast a portion of the elongate body 446, where the retractable sheath466 can move longitudinally along the elongate body 446. The valve 400can be positioned at least partially within the retractable sheath 466,where the retractable sheath 466 moves along the elongate body 446 tohelp deploy the valve 400. In one embodiment, a retraction system 468can be used to help move the retractable sheath 466, where the system468 includes one or more wires coupled to the retractable sheath 466.The wires of the retraction system 468 can longitudinally extend atleast partially through lumens in the elongate body 446. Wires of theretraction system 468 can then be used to retract the retractable sheath466 in deploying valve 400.

FIG. 4B illustrates an embodiment in which the valve 400 is beingexpanded into its fully deployed configuration while still beingreleasably joined to a delivery catheter 442. As illustrated, theretraction system 468 has been used to retract the retractable sheath466 in deploying valve 400. The first, second, and third placementguides 458, 460, and 462 have also been extended from the distal end 450of the delivery catheter 442. As compared to FIG. 4A, the first anchorframe 402 illustrated in FIG. 4B has expanded from a first predeterminedconfiguration (e.g., the undeployed configuration) to the fully deployedconfiguration as the first, second, and third placement guides 458, 460,and 462 extend beyond the distal end 450 of the delivery catheter 442.

As illustrated, the first, second, and third placement guides 458, 460,and 462 can connect to the cardiac valve 400 through the separateportions of the deployment member 444 at points symmetrically positionedaround the first anchor frame 402 of the cardiac valve 400. Othernon-symmetrical connection points for the placement guides 458, 460, and462 and the first anchor frame 402 of the cardiac valve 400 are alsopossible.

In one embodiment, as the placement guides 458, 460, and 462 areextended from the delivery catheter 442 they flare radially as the valve400 begins to move from its undeployed configuration to its deployedconfiguration. As illustrated, in one embodiment the first, second, andthird placement guides 458, 460, and 462 are positioned adjacent theanchor members 406 so as not to interfere with the anchor members 406 asthey are embedded into, for example, the cardiac tissue surrounding acardiac valve.

FIG. 4C illustrates an embodiment in which the valve 400 in its fullydeployed configuration has been released from the delivery catheter 442.In one embodiment, releasing the valve 400 in its fully deployedconfiguration can be accomplished by retracting the portions of the oneor more deployment members 444 from being in contact with the anchormembers 406. In one embodiment, this can be accomplished by pulling onthe deployment members 444 to release the cardiac valve 400 from thefirst, second, and third placement guides 458, 460, and 462 and thedelivery catheter 442. Upon removing the deployment members 444, theanchor members 406 can then move from a first predetermined shape (asillustrated in FIGS. 4A and 4B) to a second predetermined shape (asillustrated in FIG. 4C) to anchor the cardiac valve 400 to tissues.

In one embodiment, the deployment members 444 can have a variety ofconfigurations and be constructed of a variety of materials. Forexample, the deployment members 444 can have a wire configuration with asize sufficiently large to hold the anchor members 406 in the firstpredetermined shape. Examples of different configurations forcross-sectional shapes of the wire can include, but are not limited to,round, oval, square, triangular and other shape as are known. Examplesof suitable materials include medical grade stainless steel (e.g.,316L), titanium, cobalt alloys, alginate, or combinations thereof.

In an additional embodiment, the cardiac valve 400 can further include asealing material 470 positioned between the first anchor frame 406 andthe deployment member 444. In one embodiment, upon removing thedeployment member 444 to anchor the cardiac valve 400 to the tissue thesealing material 470 can swell due the presence of liquid to occupyvolume between the first anchor frame 402 and the tissue on which thevalve has been implanted so as to prevent leakage of the liquid outsideof the opening 410 of the cardiac valve 400. In alternative embodiment,the sealing material 470 can have a microcoil configuration. Examples ofmicrocoil structures include, but are not limited to, those sold by theMicrus Corporation of Sunnyvale Calif. under the trade designator “ACTMicroCoil.”

A variety of suitable materials for the sealing material 470 arepossible. For example, the sealing material 470 can be selected from thegeneral class of materials that include polysaccharides, proteins, andbiocompatible gels. Specific examples of these polymeric materials caninclude, but are not limited to, those derived from poly(ethylene oxide)(PEO), poly(ethylene glycol) (PEG), poly(vinyl alcohol) (PVA),poly(vinylpyrrolidone) (PVP), poly(ethyloxazoline) (PEOX)polyaminoacids, pseudopolyamino acids, and polyethyloxazoline, as wellas copolymers of these with each other or other water soluble polymersor water insoluble polymers. Examples of the polysaccharide includethose derived from alginate, hyaluronic acid, chondroitin sulfate,dextran, dextran sulfate, heparin, heparin sulfate, heparan sulfate,chitosan, gellan gum, xanthan gum, guar gum, water soluble cellulosederivatives, and carrageenan. Examples of proteins include those derivedfrom gelatin, collagen, elastin, zein, and albumin, whether producedfrom natural or recombinant sources.

As will be appreciated, the sealing material 470 can be presented on thefirst anchor frame 402 in such a way as to expand in volume uponcontacting the liquid. In one embodiment, in order to inhibit thesealing material 470 from swelling prior to implanting the valve 400,the sealing material 470 can be positioned between the anchor frame 402and the deployment members 444 so as to keep the sealing material 470from contacting liquid until the deployment members 444 are removed fromthe valve 400.

FIGS. 5A-5C illustrate an additional embodiment of a system 572. System572 includes valve 500, as described herein, releasably joined to adelivery catheter 574. FIG. 5A illustrates an embodiment in which thevalve 500 in an undeployed configuration is releasably joined to adelivery catheter 574. FIG. 5B illustrates an embodiment in which thevalve 500 is in its fully deployed configuration while being releasablyjoined to a delivery catheter 574. Finally, FIG. 5C illustrates anembodiment in which the valve 500 in its fully deployed configurationhas been released from the delivery catheter 574. In one embodiment, thevalve 500 can be reversibly joined to the delivery catheter 574 throughthe use of a first inflatable balloon 576, as will be discussed below.

In the example illustrated in FIGS. 5A-5C, the delivery catheter 574includes an elongate body 578 having a proximal end 580 and a distal end582. The delivery catheter 574 further includes the first inflatableballoon 576 positioned adjacent the distal end 582, and a firstinflatable lumen 584 longitudinally extending in the elongate body 578of the catheter 574 from within the first inflatable balloon 576 to thedistal end 582. As will be appreciated, an inflating apparatus 586 canbe used to inflated and deflate the first inflatable balloon 576.

In the present example, the first inflatable balloon 576 can be at leastpartially positioned within the opening 510 of the first anchor frame502. In one embodiment, the first inflatable balloon 576 can be inflatedto expand the first anchor frame 502 of the cardiac valve 500 from afirst predetermined configuration to the fully deployed configuration.

In an additional embodiment, the first inflatable balloon 576 can beused to help align the expanded cardiac valve 500 and the fibrous tissuethat surrounds cardiac valve prior to the cardiac valve 500 beingimplanted. For example, the first inflatable balloon 576 can besufficiently long that the first inflatable balloon 576 with theundeployed cardiac valve 500 (as illustrated in FIG. 5A) can be passedthrough the native cardiac valve to position the cardiac valve 500adjacent its implant site while still having a portion of the balloonadjacent the native cardiac valve. The first inflatable balloon 576 canthen be inflated to both expand the cardiac valve 500 to its undeployedconfiguration and to contact the native cardiac valve. In this way, thefirst inflatable balloon 576 has aligned the expanded cardiac valve withits vertically projecting anchoring members 506 with the fibrous tissuesurrounding the native cardiac valve. While the first inflatable balloon576 is still inflated, the delivery catheter 574 can then be pulled soas to embed and anchor the anchoring members 506 into the fibrous tissuesurrounding the native cardiac valve. The first inflatable balloon 576can then be deflated and removed leaving the cardiac valve 500 in itsimplant location.

FIGS. 6A-6D illustrate an additional embodiment of the system 672. Asillustrated, the system 672 includes valve 600, as described herein,releasably joined to a delivery catheter 674. FIG. 6A illustrates anembodiment in which the valve 600 in an undeployed configuration isreleasably joined to a delivery catheter 674. FIG. 6B illustrates anembodiment in which the first anchor frame 602 of the valve 600 is inits fully deployed configuration while being releasably joined to adelivery catheter 674. FIG. 6C illustrates an embodiment in which thesecond anchor frame 628 of the valve 600 is in its fully deployedconfiguration while being releasably joined to a delivery catheter 674.Finally, FIG. 6D illustrates an embodiment in which the valve 600 in itsfully deployed configuration has been released from the deliverycatheter 674. In one embodiment, the valve 600 can be reversibly joinedto the delivery catheter 674 through the use of the first inflatableballoon 676 and a second inflatable balloon 688, as will be discussedbelow.

In the example illustrated in FIGS. 6A-6D, the delivery catheter 674includes the elongate body 678 having a proximal end 680 and a distalend 682. The delivery catheter 674 further includes the first inflatableballoon 676 positioned adjacent the distal end 682, and the firstinflatable lumen 684 longitudinally extending in the elongate body 678of the catheter 674 from within the first inflatable balloon 676 to thedistal end 682. The delivery catheter 674 also the second inflatableballoon 688 positioned proximal to the first inflatable balloon 676,where a second inflatable lumen 690 longitudinally extends in theelongate body 678 of the catheter 674 from within the second inflatableballoon 688 to the distal end 682. As will be appreciated, an inflatingapparatus 686 can be used to inflated and deflate the first and secondinflatable balloons 676 and 688 either simultaneously or separately.

In the present example, the first inflatable balloon 676 can be at leastpartially positioned within the opening 610 of the first anchor frame602. Similarly, the second inflatable balloon 688 can be at leastpartially positioned within the opening 632 of the second anchor frame628. In one embodiment, the first and second inflatable balloons 676 and688 can be inflated to expand the first anchor frame 602 and the secondanchor frame 628, respectively, of the cardiac valve 600 from a firstpredetermined configuration to the fully deployed configuration.

In an additional embodiment, the first inflatable balloon 676 can beused to help align the expanded first anchor frame 602 of the cardiacvalve 600 and the fibrous tissue that surrounds cardiac valve prior tothe cardiac valve 600 being implanted, as discussed above. In oneembodiment, while implanting the first anchor frame 602 as discussed,the second inflatable balloon 688 remains in its deflated state at leastpartially positioned within the opening 632 of the second anchor frame628 in its first predetermined configuration.

The second inflatable balloon 688 can then be implanted through the useof the second inflatable balloon 688. For example, upon implanting thefirst anchor frame 602 the first inflatable balloon 676 can be deflated.The first anchor frame 602 is still connected to the second anchor frame628 with the struts 629. As a result, the second inflatable balloon 688can be used to maintain pressure between the first anchor frame 602 andthe tissue into which it is implanted by pulling on the deliverycatheter 674. As the tension is being applied, the second inflatableballoon 688 can then be used to expand the second anchor frame 628 ofthe cardiac valve 600 into its fully deployed configuration.

In one embodiment, the second anchor frame 628 can be implanted into anartery or vein downstream of the first anchor frame 602. For example,the at least part of the delivery catheter 674 with the cardiac valve600 could be positioned at a predetermined location such as in theregion of the aortic valve. The first anchor frame 602 could beimplanted adjacent the aortic valve, where the second anchor frame 628would be positioned and implanted into the aorta of the patient. In anadditional embodiment, the struts 629 would be sufficiently long enoughso that the second anchor frame 628 would not interfere with the inletsto the coronary arteries, such as in the ascending aorta above the leftand right coronary artery inlets. Other implant locations are alsopossible.

As will be appreciated, additional implantable medical devices mightalso be implanted in conjunction with the cardiac valve 600, asdescribed herein. For example, cardiac stents might be placed in thecoronary arteries adjacent their inlets from the aorta sinus. Stentingthe arteries in this manner may help in maintaining their patent shapeafter the cardiac valve 600 has been implanted.

The embodiments of the valve described herein may be used to replace,supplement, or augment valve structures within one or more lumens of thebody. For example, embodiments of the present invention may be used toreplace an incompetent cardiac valve of the heart, such as the aortic,pulmonary and/or mitral valves of the heart. In one embodiment, thecardiac valve can either remain in place or be removed prior toimplanting the cardiac valve discussed herein.

In addition, positioning the delivery catheter including the valve asdiscussed herein includes introducing the delivery catheter into thecardiovascular system of the patient using minimally invasivepercutaneous, transluminal catheter based delivery system, as is knownin the art. For example, a guidewire can be positioned within thecardiovascular system of a patient that includes the predeterminedlocation. The delivery catheter, including valve, as described herein,can be positioned over the guidewire and the catheter advanced so as toposition the valve at or adjacent the predetermined location. In oneembodiment, radiopaque markers on the catheter and/or the valve, asdescribed herein, can be used to help locate and position the valve.

The valve can be deployed from the delivery catheter at thepredetermined location in any number of ways, as described herein. Inone embodiment, valve of the present invention can be deployed andplaced in any number of cardiovascular locations. For example, valve canbe deployed and placed within a major artery of a patient. In oneembodiment, major arteries include, but are not limited to, the aorta.In addition, valves of the present invention can be deployed and placedwithin other major arteries of the heart and/or within the heart itself,such as in the pulmonary artery for replacement and/or augmentation ofthe pulmonary valve and between the left atrium and the left ventriclefor replacement and/or augmentation of the mitral valve. Other locationsare also possible.

As discussed herein, the valve can be deployed from the catheter in anynumber of ways. For example, the catheter can include the retractablesheath in which valve can be at least partially housed, as discussedherein. Valve can be deployed by retracting the retractable sheath ofthe delivery catheter and extending the placement guides so that thevalve expands to be positioned at the predetermined location. In anadditional embodiment, the valve can be deployed through the use of oneor more inflatable balloons, as discussed herein. In a furtherembodiment, the valve can partially self-expand upon retracting a sheathin which the valve is located, and then deployed through the use of aninflatable balloon.

Once implanted, the valve can provide sufficient contact with the bodylumen wall to prevent retrograde flow between the valve and the bodylumen wall, and to securely located the valve and prevent migration ofthe valve. The valve described herein also display sufficientflexibility and resilience so as to accommodate changes in the bodylumen diameter, while maintaining the proper placement of valve. Asdescribed herein, the valve can engage the lumen so as to reduce thevolume of retrograde flow through and around valve. It is, however,understood that some leaking or fluid flow may occur between the valveand the body lumen and/or through valve leaflets.

While the present invention has been shown and described in detailabove, it will be clear to the person skilled in the art that changesand modifications may be made without departing from the spirit andscope of the invention. As such, that which is set forth in theforegoing description and accompanying drawings is offered by way ofillustration only and not as a limitation. The actual scope of theinvention is intended to be defined by the following claims, along withthe full range of equivalents to which such claims are entitled.

In addition, one of ordinary skill in the art will appreciate uponreading and understanding this disclosure that other variations for theinvention described herein can be included within the scope of thepresent invention. For example, the anchor frame(s) and/or the leafletscan be coated with a non-thrombogenic biocompatible material, as areknown or will be known. Other biologically active agents or cells mayalso be utilized.

In the foregoing Detailed Description, various features are groupedtogether in several embodiments for the purpose of streamlining thedisclosure. This method of disclosure is not to be interpreted asreflecting an intention that the embodiments of the invention requiremore features than are expressly recited in each claim. Rather, as thefollowing claims reflect, inventive subject matter lies in less than allfeatures of a single disclosed embodiment. Thus, the following claimsare hereby incorporated into the Detailed Description, with each claimstanding on its own as a separate embodiment.

1. A cardiac valve prosthesis, comprising: only a first anchor frame consisting of a first single frame member that forms a ring around a common axis, where an infinitely vast plane parallel with and passing through the common axis and extending beyond an overall width and an overall height of the single frame member can only pass through two portions of the first single frame member to define a cross-sectional profile for each of the two portions having only one contiguous edge, and where the first single frame member has an inner portion defining an opening through the first anchor frame and an upper portion generally orthogonal to the inner portion; two or more leaflets coupled to the first anchor frame; and a pair of anchor members vertically extending from an apex of the first single frame member, the pair of anchor members restrained under tension in a first predetermined shape with a deployment member passing between the pair of anchor members, where the pair of anchor members moves toward a second predetermined shape when the deployment member is removed from between the pair of anchor members.
 2. The cardiac valve of claim 1, wherein the pair of anchor members extend parallel with the common axis that is perpendicular to a common plane extending through the first anchor frame.
 3. The cardiac valve of claim 1, wherein the pair of anchor members extend at an acute angle relative a common plane extending through the first anchor frame.
 4. The cardiac valve of claim 1, wherein the first anchor frame expands from a first predetermined configuration to a fully deployed configuration.
 5. The cardiac valve of claim 1, including a sealing material on the first anchor frame to prevent leakage of a liquid outside of the opening after anchoring the cardiac valve to tissue.
 6. The cardiac valve of claim 5, wherein the sealing material expands in volume upon contacting the liquid.
 7. The cardiac valve of claim 1, including a sealing material positioned between the first anchor frame and the deployment member, where upon removing the deployment member and anchoring the cardiac valve to tissue the sealing material prevents leakage of a liquid outside of the opening of the cardiac valve.
 8. A cardiac valve prosthesis, comprising: a first anchor frame having a first single frame member that forms a ring around a common axis to define an opening through the first anchor frame and a plurality of apexes; two or more leaflets coupled to the first anchor frame; and one or more anchor members vertically extending from each one of the plurality of apexes of the first single frame member.
 9. The cardiac valve prosthesis of claim 8, wherein the one or more anchor members extend parallel with the common axis.
 10. The cardiac valve prosthesis of claim 8, wherein the one or more anchor members extend at an acute angle relative to a common plane extending through the first anchor frame.
 11. The cardiac valve prosthesis of claim 8, wherein the first anchor frame expands from a first predetermined configuration to a fully deployed configuration.
 12. The cardiac valve prosthesis of claim 8, including a sealing material on the first anchor frame that prevents leakage of a liquid outside of the opening after anchoring the cardiac valve to tissue.
 13. The cardiac valve prosthesis of claim 12, wherein the sealing material expands in volume upon contacting the liquid.
 14. The cardiac valve prosthesis of claim 8, including a sealing material positioned between the first anchor frame and the deployment member, where upon removing the deployment member and anchoring the cardiac valve to tissue the sealing material prevents leakage of a liquid outside of the opening of the cardiac valve.
 15. A cardiac valve prosthesis, comprising: a first anchor frame having a first single frame member that forms a ring around a common axis to define an opening through the first anchor frame and an upper portion generally orthogonal to the inner portion; two or more leaflets coupled to the first anchor frame; one or more anchor members on each of an apex of the first single frame member, the one or more anchor members restrained under tension in a first predetermined shape with a deployment member passing between the two or more anchor members, where two or more anchor members move toward a second predetermined shape when the deployment member is removed from between the two or more anchor members.
 16. The cardiac valve prosthesis of claim 15, wherein the one or more anchor members extend parallel with the common axis.
 17. The cardiac valve prosthesis of claim 15, wherein the one or more anchor members extend at an acute angle relative a common plane extending through the first anchor frame.
 18. The cardiac valve prosthesis of claim 15, wherein the first anchor frame expands from a first predetermined configuration to a fully deployed configuration.
 19. The cardiac valve prosthesis of claim 15, including a sealing material on the first anchor frame that prevents leakage of a liquid outside of the opening after anchoring the cardiac valve to tissue.
 20. The cardiac valve prosthesis of claim 15, including a sealing material positioned between the first anchor frame and the deployment member, where upon removing the deployment member and anchoring the cardiac valve to tissue the sealing material prevents leakage of a liquid outside of the opening of the cardiac valve. 